Treatment of Pain in Head-and-Neck Cancer Patients: is Methadone More Effective? (310111-4)
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Purpose
Background of the study:
Treatment of Pain in Head-and-Neck Cancer Patients:
is methadone more effective than fentanyl?
Pain is a prevalent symptom in patients with cancer. A neuropathic component is seen in one third of the patients. In patients with head-and-neck cancer neuropathic pain is far more prevalent than in a general cancer population: 46-64%. Treatment of neuropathic pain is complex and available treatment modalities achieve (partial) pain relief in only 40-60% of patients. The N-Methyl-D-Aspartate Receptor (NMDAR) plays a central role in the mediation of neuropathic pain. NMDAR blockers could be a new approach to treat neuropathic pain in patients with cancer.
Methadone is a strong opioid but at the same time significant non-competitive NMDA-receptor antagonist qualities have been described. Many small studies and case-reports describe the successful rotation from different strong opioids to methadone. There are no studies that selected patients with (predominantly) neuropathic pain to be treated with methadone, whereas this group of patients is expected to profit from the NMDAR-antagonist properties of methadone.
Objective of the study:
This randomised controlled trial (RCT) aims to investigate whether addition of a NMDAR-antagonist to a strong opioid (methadone) is superior in the treatment of predominantly neuropathic pain over a strong opioid alone (fentanyl) in terms of pain relief and time to achieve significant pain relief.
Study design:
Open label randomised controlled trial
Study population:
opioid naïve patients with histological proven head-and-neck cancer and (partly) neuropathic pain with a NRS score of ≥ 4, age =/> 18 years
Intervention Treatment with methadone or fentanyl patch
Primary study parameters/outcome of the study:
Is methadone more effective than fentanyl in the treatment of pain in patients with head-and-neck cancer with respect to
- significant pain relief (reduction of Numeric Rating Scale (NRS) of 50%) and
- pain interference
Secondary study parameters/outcome of the study:
Is methadone superior to fentanyl in the treatment of pain in patients with head-and-neck cancer with respect to
- time to achieve significant pain relief
- side-effect profile?
| Condition | Intervention | Phase |
|---|---|---|
|
Pain Cancer of Head and Neck |
Drug: fentanyl Drug: methadone |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treatment of Pain in Head-and-Neck Cancer Patients: is Methadone More Effective Than Fentanyl? |
- significant pain relief (reduction of Numeric Rating Scale (NRS) of 50%) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
- time to achieve significant pain relief [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
- side-effect profile [ Time Frame: 9 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 210 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: fentanyl
active pain treatment with fentanyl patch
|
Drug: fentanyl
T = 0
T=1 1 week
T=2 3 weeks
T=3 5 weeks
T = 4 9 weeks
Other Name: Durogesic
|
|
Experimental: methadone
active pain treatment with methadone
|
Drug: methadone
T = 0
T=1 1 week
T=2 3 weeks
T=3 5 weeks
T = 4 9 weeks
Other Name: Symoron
|
Detailed Description:
Study design The duration of the study will be 9 weeks. Patients will visit the outpatient clinic 5 times. Patients of MAASTRO clinic will be seen directly before or after the radiation therapy. No extra visits will be necessary.
T= -1: - informed consent
- sort of pain (DN4)
- randomisation
T = 0 - questionnaire 1: demographic variables, disease specific variables, BPI, side effect questions, HADS, QoL
- explain and provide the pain sheet
- start methadone 2 x 2,5 mg or fentanyl patch 12 μg/uur
- breakthrough medication: 50 µg fentanyl nose spray or fentanyl stick 400 µg till 6x/day
T=1 - questionnaire 2: BPI, side effect questions, global perceived effect
1 week - review pain sheet on pain and total rescue doses
- if necessary increase dose strong opioid with 50%
T=2 - questionnaire 2: BPI, side effect questions, global perceived effect 3 weeks - review pain sheet on pain and total rescue doses
- if necessary increase dose strong opioid with 50%
- if necessary decrease dose strong opioid with 30%
T=3 - questionnaire 2: BPI, side effect questions, global perceived effect 5 weeks - review pain sheet on pain and total rescue doses
- if necessary increase dose strong opioid with 50%
- if necessary decrease dose strong opioid with 30%
T = 4 - questionnaire 3: BPI, side effect questions, global perceived effect, QoL
- if necessary increase dose strong opioid with 50%
- if necessary decrease dose strong opioid with 30%
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- opioid naive patients with histological proven head-and-neck cancer and (partly) neuropathic pain with a NRS score of =/> 4
Exclusion Criteria:
- age under 18
- not being able to read or fill in the questionnaires
- recent operation (less than 7 days)
- women of childbearing potential not using contraception
Contacts and Locations| Contact: Marieke HJ van den Beuken-van Everdingen, MD, PhD | 0031(0)433875384 | m.vanden.Beuken@mumc.nl |
| Contact: Jacob Patijn, MD, PhD | 0031(0)433876543 | jacob.patijn@mumc.nl |
| Netherlands | |
| University Hospital Maastricht | Not yet recruiting |
| Maastricht, Netherlands, 6202AZ | |
| Contact: van den Beuken-van Everdingen 0031(0)433875384 | |
| Principal Investigator: Marieke HJ van den Beuken-van Everdingen, MD, PhD | |
| Study Chair: | Maarten van Kleef, MD, PhD | Maastricht University Medical Center |
More Information
No publications provided
| Responsible Party: | prof. dr. M van Kleef, anesthesiologist, MUMC, Maastricht University Medical Center |
| ClinicalTrials.gov Identifier: | NCT01317589 History of Changes |
| Other Study ID Numbers: | METC 11-2-007 |
| Study First Received: | February 16, 2011 |
| Last Updated: | March 16, 2011 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Maastricht University Medical Center:
|
Pain Cancer of Head and Neck methadone Fentanyl |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Headache Neoplasms by Site Neoplasms Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Fentanyl Methadone Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses |
Pharmacologic Actions Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Anesthetics, Intravenous Anesthetics, General Anesthetics Analgesics, Opioid Antitussive Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on May 23, 2013